DEA Eases Requirements for Cannabidiol Trials

Now, a previously registered cannabidiol clinical researcher who is granted a waiver can readily modify his or her protocol and continue the research seamlessly.

The U.S. Drug Enforcement Administration announced Dec. 23 that it has eased some of the regulatory requirements imposed by the Controlled Substances Act for those who are conducting FDA-approved clinical trials on cannabidiol, an extract of the marijuana plant, to streamline the research process on its possible medicinal value and help foster ongoing scientific studies. DEA has notified affected researchers by letter of the changes, which took effect immediately.

A federal regulation, 21 CFR 1301.18, requires researchers conducting these clinical trials under an FDA Investigational New Drug Application to have a DEA research registration, which permits the possession of an approved amount of cannabidiol for a specific research protocol. Until now, researchers who expanded the scope of their studies and needed more of it than they were initially approved for had to request in writing a modification to their DEA research registrations. This could delay their research as the approval process included both DEA and the Food and Drug Administration.

Now, a previously registered cannabidiol clinical researcher who is granted a waiver can readily modify his or her protocol and continue the research seamlessly.

"Marijuana is a Schedule I controlled substance because of the presence of tetrahydrocannabinol (THC), marijuana's psychoactive ingredient," according to DEA's news release. "Because CBD contains less than 1 percent THC and has shown some potential medicinal value, there is great interest in studying it for medical applications. Currently, CBD is a Schedule I controlled substance as defined under the CSA. Though the FDA approves drugs for medical use in the United States, the DEA regulates the handling of all controlled substances, including those being used by researchers to conduct studies."

Product Showcase

  • Full Line of Defense Against Combustible Dust Nilfisk

    Nilfisk provides a comprehensive range of industrial vacuums meticulously crafted to adhere to NFPA 652 housekeeping standards, essential for gathering combustible dust in Class I, Group D, and Class II, Groups E, F & G environments or non-classified settings. Our pneumatic vacuums are meticulously engineered to fulfill safety criteria for deployment in hazardous surroundings. Leveraging advanced filtration technology, Nilfisk ensures the secure capture of combustible materials scattered throughout your facility, ranging from fuels, solvents, and metal dust to flour, sugar, and pharmaceutical powders. Read More

  • AirChek Connect Sampling Pump

    Stay connected to your sampling with the SKC AirChek® Connect Sampling Pump! With its Bluetooth connection to PC and mobile devices, you can monitor AirChek Connect pump operation without disrupting workflow. SKC designed AirChek Connect specifically for all OEHS professionals to ensure accurate, reliable flows from 5 to 5000 ml/min and extreme ease of use. AirChek Connect offers easy touch screen operation and flexibility. It is quality built to serve you and the workers you protect. Ask about special pricing and a demo at AIHA Connect Booth 1003. Read More

  • The MGC Simple Plus

    The MGC Simple Plus is a simple-to-use, portable multi gas detector that runs continuously for three years without being recharged or routinely calibrated after its initial charge and calibration during manufacturing. The detector reliably tests a worksite’s atmosphere for hydrogen sulfide, carbon monoxide, oxygen and combustible gases (LEL). Its durability enables the detector to withstand the harshest treatment and environments, hence earning it an IP 68 rating. The MGC Simple Plus is also compatible with a variety of accessories, such as the GCT External Pump. Visit gascliptech.com for more information. Read More

Featured

Artificial Intelligence

Webinars